NCT03197298

Brief Summary

Acute coronary syndrome (ACS) guidelines have been changed, favoring dual antiplatelet therapy (DAPT) with the more potent P2Y12 inhibitor ticagrelor over clopidogrel (besides aspirin). This change is based on studies that showed benefits of ticagrelor. However, study participants were only partly treated by percutaneous coronary intervention (PCI). In patients who were treated by PCI, this was generally performed using of bare metal or first-generation drug-eluting stents (DES). CHANGE DAPT is an investigator-initiated, prospective, single centre registry, in which we evaluate the impact of the guideline suggested change in the primary DAPT regimen (from clopidogrel to ticagrelor) on 1-year clinical outcome in ACS patients treated by PCI with newer-generation DES in the Thoraxcentrum Twente.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,062

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 21, 2012

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 25, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 25, 2016

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 23, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 23, 2017

Completed
Last Updated

June 23, 2017

Status Verified

June 1, 2017

Enrollment Period

3.6 years

First QC Date

May 23, 2017

Last Update Submit

June 22, 2017

Conditions

Acute Coronary SyndromePercutaneous Coronary InterventionDrug-Eluting Stents

Keywords

Acute Coronary SyndromePercutaneous Coronary InterventionDrug-Eluting StentsPlatelet Aggregation InhibitorsTicagrelorclopidogrelPurinergic P2Y Receptor Antagonists

Outcome Measures

Primary Outcomes (1)

  • Net adverse clinical and cerebral events (NACCE)

    A composite of all-cause death, any myocardial infarction, stroke, or major bleeding.

    1 year

Secondary Outcomes (6)

  • All-cause death

    1 year

  • Any myocardial infarction

    1 year

  • Stroke

    1 year

  • Major Bleeding

    1 year

  • Any clinically indicated revascularization

    1 year

  • +1 more secondary outcomes

Study Arms (2)

Clopidogrel Period

ACS patients treated by PCI with newer-generation DES before the guideline suggested change in primary DAPT-regimen

Drug: Clopidogrel

Ticagrelor Period

ACS patients treated by PCI with newer-generation DES after the guideline suggested change in primary DAPT-regimen

Drug: Ticagrelor

Interventions

ClopidogrelDRUG
Also known as: Plavix
Clopidogrel Period
TicagrelorDRUG
Also known as: Brilinta, Brilique
Ticagrelor Period

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients admitted to the primary cardiac care clinic of the Thoraxcentrum Twente

You may qualify if:

  • Presentation with acute coronary syndrome (ACS)
  • Treated with newer-generation drug-eluting stent (DES) in coronary artery or bypass graft lesion

You may not qualify if:

  • Known pregnancy
  • Life expectancy less than one year
  • Planned elective surgery requiring interruption of DAPT in the first 6 months
  • Known intolerance to components of the DES available
  • Indication for oral anticoagulation at baseline

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medisch Spectrum Twente

Enschede, Netherlands

Location

Related Publications (1)

  • Zocca P, van der Heijden LC, Kok MM, Lowik MM, Hartmann M, Stoel MG, Louwerenburg JW, de Man FHAF, Linssen GCM, Knottnerus IL, Doggen CJM, van Houwelingen KG, von Birgelen C. Clopidogrel or ticagrelor in acute coronary syndrome patients treated with newer-generation drug-eluting stents: CHANGE DAPT. EuroIntervention. 2017 Nov 20;13(10):1168-1176. doi: 10.4244/EIJ-D-17-00634.

    PMID: 29151439DERIVED

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

ClopidogrelTicagrelor

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

TiclopidineThienopyridinesThiophenesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingAdenosinePurine NucleosidesPurinesNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosides

Study Officials

  • Clemens von Birgelen, MD,PhD,Prof

    Thoraxcentrum Twente

    STUDY DIRECTOR

  • K. Gert van Houwelingen, MD

    Thoraxcentrum Twente

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2017

First Posted

June 23, 2017

Study Start

December 21, 2012

Primary Completion

July 25, 2016

Study Completion

July 25, 2016

Last Updated

June 23, 2017

Record last verified: 2017-06

Locations

NL(1)